Imagion Plans IND Submission for Phase 2 HER2 Breast Cancer Trial in Q3 2025
Imagion Biosystems has received encouraging feedback from the FDA on its planned Phase 2 HER2 breast cancer clinical trial, paving the way for its Investigational New Drug application submission later this year.
- Positive FDA feedback on MagSense® HER2 imaging agent
- Phase 2 clinical trial planned for HER2 breast cancer in the U.S.
- IND application submission expected in Q3 2025
- Upcoming in-person FDA meeting to finalize trial approval process
- Focus on non-radioactive, precision molecular imaging technology
Imagion Biosystems' Regulatory Progress
Imagion Biosystems Limited (ASX, IBX), a medical technology company focused on early cancer detection, has taken a significant step forward in its clinical development program. The company announced it has received formal, positive feedback from the U.S. Food and Drug Administration (FDA) regarding its planned Phase 2 clinical trial for its MagSense® HER2 imaging technology targeting breast cancer.
This feedback is a crucial milestone in the regulatory pathway, signaling that the FDA views the company’s study design and proposed outcomes favorably. The MagSense® HER2 imaging agent represents a novel, non-radioactive diagnostic approach that combines biotechnology and nanotechnology to detect cancer with greater specificity and at earlier stages than current methods.
Next Steps Toward Clinical Trial Initiation
Following this encouraging FDA response, Imagion is preparing to submit its Investigational New Drug (IND) application in the third quarter of 2025. The IND submission is a prerequisite for commencing clinical trials in the United States. The company will also hold an in-person meeting with the FDA in the coming week to finalize the review process, underscoring the collaborative nature of the regulatory engagement.
Executive Chairman Bob Proulx expressed confidence in the company’s regulatory trajectory, highlighting the constructive nature of the FDA’s input and the company’s readiness to proceed. This regulatory progress not only validates the scientific approach behind MagSense® but also enhances investor confidence in the company’s clinical and commercial prospects.
Implications for the Breast Cancer Diagnostic Landscape
If successful, Imagion’s technology could transform breast cancer diagnostics by providing a safer, more precise imaging alternative that avoids the use of radioactive tracers. This could lead to earlier detection and better patient outcomes, addressing a critical need in oncology care. The Phase 2 trial will be pivotal in demonstrating the clinical utility and safety of the MagSense® HER2 imaging agent.
While the announcement does not detail the FDA’s specific feedback or the timeline beyond the IND submission, the positive tone suggests a smoother regulatory pathway than might be typical for novel imaging agents. Investors and stakeholders will be watching closely as the company moves toward trial initiation and subsequent data readouts.
Bottom Line?
Imagion’s positive FDA engagement sets the stage for a potentially transformative breast cancer imaging trial later this year.
Questions in the middle?
- What specific FDA feedback was provided regarding trial design and endpoints?
- How might the Phase 2 trial results impact regulatory approval timelines?
- What are the commercial prospects if MagSense® proves successful in clinical trials?
